INTELLANAV XP TEMPERATURE ABLATION CATHETER, INTELLANAV MIFI XP TEMPERATURE ABLATION CATHETER, INTELLANAV ABLATION CATHE
FDA premarket approval P020025/S077 · decided 2016-02-24
Approval details
- PMA number
- P020025
- Supplement
- S077
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INTELLANAV XP TEMPERATURE ABLATION CATHETER, INTELLANAV MIFI XP TEMPERATURE ABLATION CATHETER, INTELLANAV ABLATION CATHE
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2015-07-24
- Decision date
- 2016-02-24
- Days to decision
- 215 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for design changes to incorporate a magnetic sensor into the IntellaTip XP and MiFi XP Temperature Ablation Catheters. The device, as modified, will be marketed under the trade name IntellaNav Xp Temperature Ablation Catheter and IntellaNav MiFi XP Temperature Ablation Catheter.
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